Efficacy of Qualia Testosterone+ on Testosterone Levels in Adult Males

NCT07556458 | Not Yet Recruiting

• 1 other identifier: QLS-022
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a randomized, double-blind, placebo-controlled, triple-arm, parallel-group study evaluating the efficacy and tolerability of two distinct Qualia Testosterone+ formulations, novel dietary supplements formulated to support endogenous testosterone, in adult males aged 28-65. Approximately 75 participants will be randomized equally to receive Qualia Testosterone+ Formula 1, Qualia Testosterone+ Formula 2, or a matched placebo (3 capsules once each morning) for 28 days. The primary outcome is between-group change in total testosterone from baseline to day 28. Secondary outcomes include changes in free (dialysis) testosterone, the Aging Male Symptoms Scale, the PROMIS Short Form v1.0 - Fatigue 10a, and safety and tolerability assessments. Blood samples will be collected in a clinical laboratory setting, while symptom and safety assessments will be completed electronically at home.

Conditions

Low Testosterone Levels

Keywords

Testosterone; Dietary Supplement; Male Vitality

Outcome Measures

Primary Outcomes (1)

• Change in Total Testosterone Levels

  Between-group change in serum total testosterone concentration from baseline to Day 28, measured via venous blood draw analyzed by a CLIA-certified laboratory. Comparison across Qualia Testosterone+ Formula 1, Formula 2, and Placebo groups using linear mixed-effects models.

  Baseline and Day 28

Secondary Outcomes (6)

• Change in Free (Dialysis) Testosterone Levels

  Baseline and Day 28

• Change in Aging Males' Symptoms (AMS) Scale Score

  Baseline and Day 28

• Change in PROMIS Fatigue 10a Score

  Baseline and Day 28

• Safety and Tolerability

  Baseline through Day 14 and Day 28

• Within group difference in total testosterone

  Baseline to 28 days

Study Arms (3)

Qualia Testosterone+ Formula 1

EXPERIMENTAL

Participants receive 3 capsules daily of Qualia Testosterone+ Formula 1 dietary supplement for 28 days.

Dietary Supplement: Qualia Testosterone+

Qualia Testosterone+ Formula 2

EXPERIMENTAL

Participants receive 3 capsules daily of Qualia Testosterone+ Formula 2 dietary supplement for 28 days.

Dietary Supplement: Qualia Testosterone+

Placebo

PLACEBO COMPARATOR

Participants receive 3 capsules daily of matching placebo for 28 days.

Other: Placebo

Interventions

Qualia Testosterone+ DIETARY_SUPPLEMENT

Qualia Testosterone+ dietary supplement capsules (Formula 1 or Formula 2). Participants take 3 capsules daily with breakfast for 28 days. The supplement contains a proprietary blend of ingredients designed to support healthy testosterone levels.

Qualia Testosterone+ Formula 1; Qualia Testosterone+ Formula 2

Placebo OTHER

Matching placebo capsules. Participants take 3 capsules daily with breakfast for 28 days.

Placebo

Eligibility Criteria

• Age: 28 Years - 65 Years
• Gender Eligibility Details: Male participants only. This study evaluates the effects of a dietary supplement on testosterone levels in adult males.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide voluntary, written, informed consent to participate in the study
• Agree to provide a valid cell phone number and are willing to receive communications through text
• Can read and write English
• Willing to not begin taking any new supplements during the study and continue taking any supplements they are currently using regularly
• Willing to complete questionnaires, records, and diaries associated with the study.
• Male participants aged 28-65
• A ≤500 ng/dL Total Testosterone at baseline
• Willing and able to visit a local blood draw facility for required blood sample collections
• Live within 20 miles of a suitable blood draw facility
• Willing to not consume any supplements containing Testosterone or botanicals known to impact hormones starting about 2 weeks prior to the baseline blood test and continuing through the intervention period.

You may not qualify if:

• Known food intolerances/allergy to any ingredients in the product
• Having any of the following conditions: Psychiatric conditions, neurologic disorders, endocrine disorders, cancer
• Having had a significant cardiovascular event in the past 6 months
• Taking MAO inhibitors, SSRIs, blood thinners, or any other psychiatric or neurological medicines
• On immunosuppressive therapy
• Individuals who were deemed incompatible with the test protocol
• Adults lacking capacity to consent
• Female
• Have Hypogonadism
• On Testosterone Replacement Therapy
• Taking Gonadotropin-releasing hormone (GnRH) injections or gonadotropins (hCG or FSH)

Sponsors & Collaborators

• Qualia Life Sciences: lead

Study Officials

• Colin Gardner, PhD

  Qualia Life Sciences, LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colin Gardner, PhD

CONTACT

678-387-7924; colin@qualialife.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 29, 2026
• Study Start: April 8, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 3, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share